Cardiff Wound Impact Schedule: the development of a condition-specific questionnaire to assess...

Cardiff Wound ImpactSchedule: the developmentof a condition-specificquestionnaire to assesshealth-related quality of lifein patients with chronicwounds of the lower limbPatricia Price, Keith Harding

ABSTRACTThe purpose of this study was to develop and validate a questionnaire to measure the impact of chronic wounds(leg ulcers and diabetic foot ulcers) on patient health-related quality of life (HRQoL) and identify areas of patientconcern. The Cardiff Wound Impact Schedule (CWIS) was created following a three-stage process. Stage 1included a focus group (n = 10) and a series of semi-structured interviews (n = 13) to generate items for thequestionnaire. Stage 2 involved piloting the 28-item questionnaire on 124 patients (64�5% with leg ulcerationand 35�5% with diabetic foot ulceration): data from this stage were analysed using factor analysis. The reliability,validity and reproducibility of the resulting scale were assessed in Stage 3, a 3-month follow-up study of 135patients in which patients completed the CWIS and the SF-36. Factor analysis identified three domains of HRQoL:physical symptoms and daily living, social life and well-being. There were no significant differences in scoresacross the wound types. Internal consistency was good (�= 0�77—0�96) as was reproducibility (P < 0�001). TheCWIS was able to discriminate between those with healed ulcers and active ulcers (P < 0�01). Construct validitywas demonstrated by strong correlations between related items on CWIS and SF-36 (P < 0�01—P < 0�0001). Thedata suggest that CWIS has high internal consistency and the ability to discriminate between health states andgood reproducibility. CWIS is a valid tool for studying the impact of chronic wounds of the lower leg on HRQoL.CWIS allows clinicians to identify items of patient concern, which can then be used to negotiate options of caremost suited to individual patients.

Key words: Quality of life assessment tool . Health-related . Wound care . Questionnaire . Chronic lower limb wounds

INTRODUCTIONThe presence of a chronic non healing woundcan result in a profound impact on everydaylife. Chronic leg ulceration represents a majorhealth problem for many people over the ageof 60, affecting in the region of 0�1—0�3% of thegeneral population, although this figure risesto 2% in complications over the age of 80 (1).Foot complication associated with diabetesmellitus is also a major problem (2); for such

Authors: P Price, PhD, Wound Healing Research Unit, Universityof Wales College of Medicine, Heath Park, Cardiff, UK; K Harding,FRCS, Wound Healing Research Unit, University of Wales Collegeof Medicine, Heath Park, Cardiff, UKAddress for correspondence: Prof. P Price, Wound HealingResearch Unit, University of Wales College of Medicine, HeathPark, Cardiff CF14 4UJ, UKE-mail: [email protected]

� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 110

& RESEARCH

individuals, the development of neuropathycan lead to foot wounds that can result inamputation. The presence of foot ulcerationis a strong predictor of further foot deteriora-tion, with major impacts on an individual’sQoL (3). This article outlines the developmentof a condition-specific tool to measure theimpact of these two chronic wound types onpatients’ self-reported QoL.

The main focus of treatment for patientswith chronic wounds is complete healing,with the aim of achieving a healed state asquickly as possible. Even so, patients face theprospect of challenging local and systemiccare with frequent dressing changes, episodesof infection, a possible cycle of re-ulcerationand fears of a deteriorating health state. Therehas also been debate about the existence of asubgroup of patients for whom healing is nota possible outcome (4) but for whom QoLissues remain paramount.

A limited amount of work has already beencompleted in the investigation of the impact ofa chronic wound on health-related QoL(HRQoL). A number of qualitative studieshave been completed that outline the extentof the impact of a wound on everyday livingfor patients with chronic leg ulceration (5—12),but there has been less work on diabetes-related foot problems (13—15). General healthstatus has also been investigated using generictools for those with chronic leg ulceration(16—20) and for those with diabetes-relatedfoot ulceration (21). In the majority of thesestudies, those with chronic wounds arereported to experience poorer HRQoL thansex- or age-matched controls.

It is, however, increasingly recognised thatsuch generic measures do not address areasthat are salient to specific diseases or healthstates. Condition-specific instruments aremore likely to be relevant to areas prioritisedby the attending clinicians and contain itemsconsidered important by the relevant patientgroup (22,23). Condition-specific measureshave been developed which relate to venousdisease generally (24—27), to leg ulcerationspecifically (28) and diabetic peripheral neu-ropathy (29) or foot ulcer problems (30,31), butno scale exists that focuses on chronic woundsirrespective of aetiology.

The development of such a scale wouldallow for the HRQoL of patients with chronicwounds to be more fully understood, leading

to possible changes in clinical practice if sucha questionnaire were to be fully adopted. Oneof the concerns about the transformation ofHRQoL from a speculative concept to a recog-nised clinical endpoint is that, to date, theconcept has not really been introduced intoroutine clinical practice (32). This studyaimed to produce a questionnaire that wouldprovide both a valid and a reliable form ofmeasuring condition-specific QoL across arange of wound types and a framework forinforming clinicians about specific areas ofpatient concern that could be used for jointprioritisation of clinical care. The aim wasalso to develop an instrument sufficientlyshort and easy to use, so that it could beused in a range of health care settings and inboth research and clinical work. This articleoutlines the development and validation ofthe Cardiff Wound Impact Schedule (CWIS)for use with patients with chronic wounds.The underlying philosophy behind the devel-opment of the tool was the involvement of thepatient both in the construction of the instru-ment and in the weighting of the importanceof issues to them as individuals.

METHODS

Stage 1: item generationIt is generally agreed that the content ofHRQoL instruments should be based directlyon the information provided by relevantpatients, in terms of both coverage of relevantitems and the specific wording of questions(33). A focus group was held, involving 10patients (three males and seven females,mean age = 74�3 years; SD = 4�9) presenting ata specialist outpatient clinic with chronic nonhealing wounds that had been present for aminimum of 3 months. The point at which nonew themes or ideas emerged from the groups(thematic exhaustion) determined the end ofthe session. Patients were asked to describethe impact of the wound on their everydaylives, and a list of topics was compiled fromthe session.

In-depth semi-structured interviews with 13patients (one male and 12 females, meanage = 83�5 years; SD = 3�2) who presented tothe same specialist unit were completed. Theinterviews took place in the patients’ homesand lasted about an hour. Patients were askedabout their everyday experiences of living with

Key Points

. a limited amount of work hasalready been completed in theinvestigation of the impact of achronic wound on health-relatedquality of life (HRQoL)

. this article outlines the develop-ment and validation of the CardiffWound Impact Schedule (CWIS)

. a three stage process was usedto develop and validate the tool

Cardiff Wound Impact Schedule

� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 1 11

a non healing wound and to identify theaspect of this experience that they foundstressful. All interviews were tape-recordedfor subsequent analysis, when commonthemes were identified using content analysis.A subset of tapes were analysed by a secondresearcher to minimise bias at this stage (inter-rater reliability was 93%).

Stage 2: scale generationThe information from Stage 1 was used tocompile a 28-item questionnaire, which waspiloted on 50 consecutive consenting patientswith chronic wounds attending a specialistoutpatient clinic (half with leg ulceration andthe others with diabetic foot wounds), none ofwhom had been involved in Stage 1. Themale : female ratio was 23 : 27, with an agerange of 34—90 years and a mean age of 65�9years. Patients completed the questionnairewhilst sitting in the waiting area of the out-patient clinic; those who experienced anyvisual or writing difficulties were assisted bya researcher. Patients were asked to indicatethe extent to which they had experienced adifficulty in relation to the presence of awound plus the extent to which they foundthat experience stressful.

In addition, a further 74 patients completedthe questionnaire using a postal method. Thepatients were asked to complete the questionsrelating to their experiences during the pastweek and to comment on the wording andlayout of the questionnaire. The mean age ofthis group was 70�4 years (range 48—86�2); 49were females and 25 were males. Seventy-fiveper cent had chronic leg ulceration; theremaining 25% had diabetes-related footulceration. There were no statistical differ-ences in the number of missing items betweenthose who completed the questionnaire athome or at the clinic.

Stage 3: testing reliability and validityA new version of the questionnaire was devel-oped on the basis of the results from Stage 2.In addition, an overall rating of HRQoL usinga 10-point scale was included, plus a rating ofsatisfaction with an individual’s overallHRQoL.

The validity and reliability of the resultingscale was assessed in a survey of 150 patientsattending two specialist wound outpatient

clinics. One hundred and thirty-five patientsagreed to participate, giving a 90% responserate. This stage included the completion of theCWIS and the SF-36 Health Survey Question-naire (34), plus a clinical indication of thewound state (healed versus non healed): therespondents completed the questionnaireswhilst waiting for their clinic appointment.Although half of the patients were asked tocomplete the SF-36 first and the other half tocomplete the CWIS first (to avoid ordereffects), there is no guarantee that patientscomplied with these instructions. These datawere used to determine the construct validityof the new measure. The mean age of thissample was 65�9 years (range 43—85�5 years),with 55% of the sample males and 45%females. Fifty-four of the patients had a dia-betic foot wound and 81 had chronic legulceration, with only 30 of these patientsliving alone.

In addition, a second copy of the CWIS wasgiven to patients in an envelope to completewithin 5—7 days after attending the clinic,together with a stamped, addressed envelopeto return the completed questionnaire. Thesedata allowed for the calculation of test—retestreliability of the CWIS to be assessed. Ninetypatients returned their second questionnaire,giving a response rate of 66%. The seniorclinician responsible for the clinical care ofthese patients reported no important changesin their health status during this short timeperiod.

Three months (±1 week) later, all 135patients completed the CWIS at a follow-upclinic visit. The health status of the patientswas assessed by the consultant and classifiedas ‘wound present’ or ‘wound healed’.

RESULTSThere were no significant differences in thescores of patients, dependent on woundtype. This section therefore includes theresponses of all patients who participated inthe study.

Scale generationThe data from Stage 2 were factor analysedusing varimax rotation to determine thefactors underlying the scale. The three factorswith Eigen values greater than 1�5 wereretained; these three factors contained 26

Key Points

. an initial 28-item questionnairewas piloted on 50 patients withchronic wounds, attending aspecialist outpatient clinic

. additionally a further 74 patientswere evaluated using a postalmethod

. a second improved questionnairewas developed and 150 patientssurveyed during clinic visits

. a follow-up questionnaire whichpatients returned 5—7 days afterinitial evaluation allowed follow-up



items and explained 51% of the variance. Onlytwo items caused any problems, these were‘limited contact with family/friends’ and‘family/friends being overprotective’. Theseitems loaded onto more than one factor.However, given the qualitative commentsfrom earlier stages and the views of theclinician involved, these items were retainedwithin those scales that produced the mostmeaningful scales. Two items were with-drawn from the scale as they did not loadonto any one factor (i.e, ‘changes in appetite’and ‘I look forward to clinic visits’). Thisresulted in three scales:

. Physical symptoms and everyday living(12 items rated for the extent of the pro-blem and associated stress, each on a 5-point scale): this domain focuses on theimpact of symptoms on daily functioningand comfort.

. Social life (seven items rated for theextent of the problem and associatedstress, each on a 5-point scale): thisdomain focuses on the individual’s abil-ity to get out and about.

. Well-being (seven items rated on a 5-point scale): this domain focuses on thepatient’s well-being in relation to thewound, particularly anxieties aboutoutcome.

Examples from each of the subscales areshown in Figure 1 and the factor loadings forthe scales are summarised in Table 1.

To calculate the scale scores, the items foreach scale are summated. For ‘physical

symptoms and everyday living’ and ‘sociallife’, the items are rated for the extent of theexperience of the item during the past weekand how stressful that experience was on anitem-by-item basis. This allows the patients toweight the items included in the scale. Forexample, the experience of ‘disturbed sleep’may be rated as ‘rarely’ but ‘very stressful’.Thus, the total score includes the patient’sperception of the experience and the asso-ciated stress. The well-being scale is scoredon a 5-point Likert scale, with responseoptions from ‘strongly agree’ to ‘stronglydisagree’. All three scales are then trans-formed onto a 0—100 scale, where a highscore indicates a positive rating.

ReliabilityInternal consistency was calculated usingCronbach’s alpha (35), values of which rangefrom 0 to 1. Coefficients above 0�7 are gener-ally regarded as acceptable for psychometricmeasurements (26). Cronbach’s alpha was cal-culated for the three factors within CWIS.Each of the subscales resulted in an alpha>0�75 [physical symptoms and everydayliving (experience alpha = 0�88 and stress

alpha = 0�95), social life (experience alpha = 0�96and stress alpha = 0�93) and well-being(alpha = 0�77). These findings confirm thatthe internal consistency is high.

ReproducibilityA specific test—retest component was includedwithin Stage 3 of the development of the

Key Points

. three scales were used in theevaluation— physical symptoms and every-

day living— social life— well-being

. to calculate the scale, scores andnumber of sub-evaluations aresummated

. all evaluations and summationswere rigorously checked for relia-bility and reproducibility usingspecific statistical approaches

Physical symptoms and daily living

Have you experienced any of the following during the past week?

Disturbed sleep

Not at all/Not applicable

Seldom Sometimes Frequently Always

Social life

Have you experienced any of the following during the past week?

Difficulty getting out andabout


Seldom Sometimes Frequently Always

Well-being

To what extent do you agree/disagree with the following statements?

I feel anxious about mywound(s)

Stronglydisagree

Disagree Not sure Agree Stronglyagree

Physical symptoms and daily living

How stressful has this experience been for you?

Disturbed sleep


Slightly Moderately Quitea bit

Very

Social life

How stressful has this experience been for you?

Difficulty getting out andabout


Slightly Moderately Quitea bit

Very

Figure 1. Examples of items from each of the subscales of Cardiff Wound Impact Schedule.



questionnaire to confirm that items were answeredin a similar way by stable patients within a shorttime scale (5—7 days). Correlation coefficients forexperience of items and their associated stress

between the two time points are summarised inTable 2; all are significant at P < 0�001, indicating ahigh level of reproducibility.

Discrimination between health statesThe ability of CWIS to discriminate betweenhealth states (healed versus non healed) wascalculated using independent t-tests to ana-lyse the scores of patients in the 3-monthfollow-up. Those identified as ‘healed’ hadconsistently higher scores across the three

Key Points

. the results were also tested for dis-crimination between health statesi.e. can the tool discriminate bet-ween healed and non healed

Table 1 Factor analysis: Stage 2 (n = 124)

Factor 1 Factor 2 Factor 3

Disturbed sleep 0�749 0�108 0�009

Mobility around home 0�721 0�038 0�27

Pain 0�770 0�306 0�123

Discomfort with bandages 0�769 0�118 0�346

Difficulty in everyday tasks 0�743 0�252 0�244

Mobility outside home 0�707 0�063 0�191

Leakage 0�703 0�047 0�384

Odour 0�679 0�214 0�244

Difficulties in bathing 0�574 0�192 0�358

Difficulties with footwear 0�530 0�179 0�127

Time needed to look after the wound 0�566 0�204 0�024

Financial difficulties 0�421 0�249 0�179

Getting out and about 0�207 0�729 0�254

Relying more on others 0�351 0�641 0�032

Enable to enjoy usual social life 0�262 0�638 0�006

Not going out for fear of bumping wound 0�204 0�566 0�024

Limited contact with family and friends 0�137 0�572 0�496

Wanting to withdraw from others 0�055 0�565 0�326

Family/friends being overprotective 0�156 0�470 0�320

Anxious about the wound 0�192 0�144 0�760

Worry about recurrence 0�299 0�286 0�641

Frustration at the time to healing 0�201 0�216 0�629

Appearance of the wound is upsetting 0�239 0�327 0�619

Anxious about bumping the wound 0�264 0�363 0�609

Worry about the impact on family/friends 0�348 0�118 0�544

Confident the wound will heal 0�013 0�261 0�441

Eigen values 9�31 2�27 1�92

% of variance explained 36�26 8�12 6�87

Table 2 Pearson’s correlation coefficients components of Cardiff Wound Impact Schedule on day 1 and 5—7 days later (n = 90)

Correlation coefficients

Experience Associated stress

Physical functioning and everyday living 0�93 0�86

Social functioning 0�93 0�92

Well-being 0�90 —

Global HRQoL 0�92 —

Satisfaction with HRQoL 0�93 —

Values are significant at P < 0�001. HRQoL, health-related quality of life.



subscales, and differences between the twogroups were all significant (Table 3). Althoughthe global ratings for HRQoL were higher forthose with a ‘healed wound’, the differencewas not significant, but satisfaction withHRQoL was significantly higher for thisgroup (P < 0�01).

Relationship between CWIS and SF-36The construct validity was examined by cor-relating scales in CWIS with relevant scales ofSF-36. Physical symptoms and everyday liv-ing total score (CWIS) correlated with physicalfunction (SF-36) (r = 0�53, P < 0�0001). Specificitems on CWIS related to mobility and itsassociated stress correlated with physicalfunction (SF-36) at between r = 0�34—0�52 (allitems P < 0�0001). Items related to pain andthe associated stress (CWIS) correlated withbodily pain (SF-36) (r = –0�53, P < 0�0001: cor-relation is negative due to the different direc-tion of the scales). Social life (CWIS) correlatedwith social functioning (SF-36) (r = 0�47,P < 0�0001) and role limitation (physical)(r = 0�56, P < 0�0001). Well-being (CWIS) corre-lated with mental health (SF-36) (r = 0�217,P = 0�01) and role limitation (emotional) (SF-36)(r = 0�332, P < 0�0001).

DISCUSSIONIndividuals with chronic non healing woundsmay experience a wide range of adverseeffects on their everyday lives. Studies todate have either focused on one type ofwound (e.g. leg ulceration), have used quali-tative methods or generic tools. However,there are a number of aspects of experienceof living with a chronic wound that are notaddressed by generic instruments. Problemssuch as leakage and odour are not assesseddirectly by such instruments, yet can have aprofound impact on the patient’s life.

The results of this study suggest that thecontent of the CWIS is appropriate for indi-viduals with chronic wounds, with high inter-nal consistency, the ability to discriminatebetween health states and good reproducibil-ity. Further studies that confirm the factoredscales used in CWIS are currently beingundertaken. It is also important to increasethe sample size involved in such studies toensure the representativeness of the itemsincluded in the tool, which are currentlybased on patients from a relatively small geo-graphical area (South Wales).

In addition, the scales correlate well withrelevant scales from a well-validated generictool (SF-36). Whilst the correlations are notvery strong, the patients involved in thisstudy were all elderly and many had otherconcomitant disorders of older age (e.g.arthritis). As such, items from CWIS thatfocus directly on the symptoms of a woundare sensitive to experiences directly attribut-able to that wound, but the profile may not bematched by responses to items on a genericquestionnaire that focus on a general level offunctioning. These data support the use ofboth a generic and a condition-specific toolfor the measurement of HRQoL.

In order for the tool to be useful in clinical trialsrelated to a range of chronic wounds, CWIS needsto isolate the impact of the experiences of awound from those related to other factors presentin this age group. Whilst this is a difficult task, theability of CWIS to discriminate between differenthealth states indicates that the tool is sensitive tothis issue. The profile of scores using CWIS acrosswound types was similar, with no significant dif-ferences in scores dependent on wound type.Further studies which analyse scores related toseverity of wound rather than ‘healed’ versus‘non healed’ need to be completed to maximisethe potential for use in clinical trials.

Key Points

. current assessment and evalua-tion tools generally don’t dealwith patients’ problems such asleakage and odour

. such parameters can have pro-found impact on the patient’s life

. results of the study indicate thatthe CWIS tool is appropriate forindividuals with chronic woundswith high internal consistencyand the ability to discriminatebetween health states withgood reproducibility

Table 3 Mean scale scores for Cardiff Wound Impact Schedule by clinical assessment of healed status of wound

Healed (n = 46) Nonhealed (n = 89) P-value

Physical symptoms and everyday living 87�6 71�7 <0�0001

Social life 84�7 76�1 0�025

Well-being 50�8 38�7 <0�0001

Global HRQoL 7�2 6�9 NS

Satisfaction with HRQoL 7�8 6�7 <0�01

HRQoL, health-related quality of life; NS, not significant.



In the area of wound healing, the focus hasbeen on healing as the only measure of suc-cess. Many patients with chronic wounds willnot heal speedily despite optimum care (4);indeed complete healing may be an unrealisticgoal for this subset of patients such thatHRQoL becomes a particularly significantpart of planning care. Traditionally, the inte-gration of HRQoL issues into clinical care hasbeen done on an informal basis, without thesupport of well-defined measurement tools.The use of CWIS in a routine clinical settingis currently under investigation. The ‘stress’component of the scales gives a useful guideto a clinician of the concerns that a givenpatient may have at any one time. The stressscale, particularly in relation to physical symp-toms and everyday life, can form the basisfor patient involvement in clinical decision-making. This requires the clinician to besensitive to those aspects of the wound thatare most stressful to the individual and usethat information to guide clinical decisions orto prioritise information/educational inputwith the patient. In addition, the well-beingscale allows for clinician—patient communica-tion to focus on the worries of the patient. Thelong-term goal is for CWIS to be used routinelyas part of clinical assessment and care planning.

The questionnaire was developed with theaim of producing an instrument that could beused with several chronic wound types. Theaim was also to develop an instrument suffi-ciently short and easy to use, so that it couldbe used in a range of health care settings andin both research and clinical work. The devel-opment of such a tool is an essential step if weare to evaluate interventions across a range ofwounds, particularly given the necessity formultiprofessional teams to provide compre-hensive care for such patients. This articleprovides evidence of a patient-centred toolwhich focuses on the concerns of the indivi-dual whilst retaining psychometric integrity.Additional work is now required to evaluateits use in clinical trials and health-care settingsto confirm the current promising data.

ACKNOWLEDGEMENTSThe authors thank Smith and Nephew Ltd(Medical) for an unrestricted research grantused for the initial stages of this work.

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Key Points

. HRQoL is a significant compon-ent of planning care for patients

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. the long term goal is for theCWIS to be used routinely aspart of clinical assessment andcare planning



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